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Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
Sponsor: Hospital for Special Surgery, New York
Summary
Differentiating between septic arthritis and other causes of joint inflammation in pediatric patients is challenging and of the utmost importance because septic arthritis requires surgical debridement as part of the treatment regimen. The current gold standard to diagnose septic arthritis in children is a positive synovial fluid culture; however, joint cultures may take several days to return. If a bacterial infection is present, it requires immediate surgical intervention in order to prevent lasting articular cartilage damage. Frequently surgeons must decide whether to surgically debride a joint before culture results are available. There is no single lab test or clinical feature that reliably indicates bacterial infection over other causes of joint inflammation. The alpha-defensin assay has shown high sensitivity and specificity for joint infection in other studies.The purpose of this study is to determine the sensitivity and specificity of several synovial biomarkers for diagnosing pediatric septic arthritis.
Key Details
Gender
All
Age Range
Any - 17 Years
Study Type
INTERVENTIONAL
Enrollment
442
Start Date
2016-06-28
Completion Date
2026-05
Last Updated
2025-06-22
Healthy Volunteers
No
Conditions
Interventions
Synovial Alpha-defensin assay
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Synovial Neutrophil elastase assay
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Synovial lactate assay
Synovial Fluid (joint fluid) will be sent out to CD Diagnostics for this test.
Synovial C-reactive Protein (CRP)
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Synovial Staphylococcus spp antigen panel
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Synovial Candida spp antigen panel
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Synovial Enterococcus faecalis assay
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Synovial bacterial culture by BacT/Alert
The synovial fluid (joint fluid) sent to CD Diagnostics for testing will also be cultured to see if any organisms grow.
Synovial Cell count + differential (CBC)
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Synovial Gram Stain
This will be performed by CD Diagnostics if any organisms are present in the synovial fluid.
Synovial Leukocyte Esterase Test Strips
These test strips will be tested at the hospital where the patient is being seen, a few drops of synovial fluid will be used on the strip.
Synovial PCR for Kingella kingae
In participants \< 8 years old, a sample of synovial fluid will be tested for Kingella kingae using PCR.
Serum Cell count + differential (CBC)
A blood test performed at the hospital.
Serum erythrocyte sedimentation rate (ESR)
A blood test performed at the hospital.
Serum C-reactive Protein (CRP)
A blood test performed at the hospital.
Serum D-dimer
A blood test performed at the hospital.
Serum Procalcitonin
A blood test performed at the hospital.
Blood Cultures
Blood will be cultured at the hospital to see if any organisms grow.
Optional blood testing per standard of care (ASO, anti-strep, ANA, anti-DS-DNA, HLA-B27, RF, Lyme and other inflammatory/ rheumatologic markers )
In patients with suspected inflammation/infection, there are other blood tests which may be standard of care and used for diagnosis.
Locations (3)
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Hospital for Special Surgery
New York, New York, United States
Campbell Clinic
Collierville, Tennessee, United States